Patient interface device having cam wheel adjustment mechanism

ABSTRACT

A patient interface device includes a cushion member having a main body portion having a surface structured to engage a face of a patient. A frame member is coupled to the cushion member, and a fluid coupling conduit is coupled to the frame member. An engagement member is coupled to the cushion member; and a rotatable cam wheel is disposed between the frame member and the engagement member. Rotation of the cam wheel changes a position of the main body portion relative to the frame member. The cushion member includes a flexible portion adjacent the main body portion, and the cam wheel is rotatable about the flexible portion, such that rotation of the cam wheel about the flexible portion causes the flexible portion to deflect thereby moving the cushion member relative to the frame member.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Divisional under 35 U.S.C. § 120 of U.S. patentapplication Ser. No. 14/282,555, filed May 20, 2014, which is aDivisional under 35 U.S.C. § 120 of U.S. patent application Ser. No.13/320,796, filed Nov. 16, 2011, now U.S. Pat. No. 8,746,249, grantedJun. 10, 2014 which claims the priority benefit under 35 U.S.C. §119(e)of U.S. Provisional Application No. 61/309,914, filed on Mar. 3, 2010,the contents of which are herein incorporated by reference.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The present invention relates to patient interface devices fortransporting a gas to and/or from an airway of a user, and, inparticular, to a patient interface device including a cam wheeladjustment mechanism for dynamically adjusting a component of thepatient interface device, such as a mask, cushion, or forehead support.

2. Description of the Related Art

There are numerous situations where it is necessary or desirable todeliver a flow of breathing gas non-invasively to the airway of apatient, i.e., without intubating the patient or surgically inserting atracheal tube in their esophagus. For example, it is known to ventilatea patient using a technique known as non-invasive ventilation. It isalso known to deliver continuous positive airway pressure (CPAP) orvariable airway pressure, which varies with the patient's respiratorycycle, to treat a medical disorder, such as sleep apnea syndrome, inparticular, obstructive sleep apnea (OSA), or congestive heart failure.

Non-invasive ventilation and pressure support therapies involve theplacement of a patient interface device including a mask component onthe face of a patient. The mask component may be, without limitation, anasal mask that covers the patient's nose, a nasal cushion having nasalprongs that are received within the patient's nares, a nasal/oral maskthat covers the nose and mouth, or a full face mask that covers thepatient's face. The patient interface device interfaces the ventilatoror pressure support device with the airway of the patient, so that aflow of breathing gas can be delivered from the pressure/flow generatingdevice to the airway of the patient. It is known to maintain suchdevices on the face of a wearer by a headgear having one or more strapsadapted to fit over/around the patient's head.

Because such patient interface devices are typically worn for anextended period of time, it is important for the headgear to maintainthe mask component of the device in a tight enough seal against thepatient's face without discomfort. A number of different adjustmentmechanisms for adjusting a component, such as a mask, of a patientinterface device are known, including adjustment mechanisms that arebased on sliding members, screw mechanisms, and pivoting arms, amongothers. However, all of these known mechanisms are based on a linearadjustment theory, and thus have a range of motion that goes eitherinward or outward with respect to the patient's face. There is thus roomfor improvement in the area of patient interface device adjustmentmechanisms.

SUMMARY OF THE INVENTION

In one embodiment, a patient interface device is provided that includesa support structure, a pivot arm pivotably coupled to the supportstructure and structured to pivot about an axis, a patient couplingmember, such as a mask, cushion, or a forehead support, coupled to thepivot arm, and a cam wheel rotateably coupled to the support structureand engaging the pivot arm, wherein rotation of the cam wheel relativeto the support structure and the pivot arm causes the pivot arm to pivotabout the axis and the patient coupling member to move either forward orbackward along a path of movement.

In one exemplary embodiment, a patient interface device is provided thatincludes a support structure forming part of a headgear of the patientinterface device, the support structure having a post portion having afirst arm having a first aperture and a second arm having a secondaperture, a pivot arm conduit pivotably coupled to the post portion andstructured to pivot about an axis, wherein the pivot arm conduit has afirst post rotateably received with the first aperture and a second postrotateably received with the first aperture, a patient coupling member,such as a mask, fluidly coupled to the pivot arm conduit, and a camwheel rotateably coupled to the support structure and engaging the pivotarm, wherein the post portion of the support structure is receivedthrough the cam wheel and the cam wheel is positioned between a baseportion of the support structure and the pivot arm conduit, and whereinrotation of the cam wheel relative to the support structure and thepivot arm conduit causes the pivot arm conduit to pivot about the axisand the patient coupling member to move either forward or backward alonga path of movement.

In another exemplary embodiment, a patient interface device is providedthat includes a support structure having a post portion having a firstpost and a second post extending therefrom, a patient coupling member,such as a mask, fluidly coupled to the support structure, a pivot armconduit pivotably coupled to the post portion and structured to pivotabout an axis, wherein a first end of the pivot arm includes a loopportion having a first aperture and a second aperture provided therein,wherein the post portion is received through the loop portion, whereinthe first post is rotateably received within the first aperture and thesecond post is rotateably received within the second aperture, aforehead support coupled to a second end of the pivot arm, and a camwheel rotateably coupled to the support structure and engaging the pivotarm, wherein the cam wheel is positioned between a base portion of thesupport structure and the loop portion, and wherein rotation of the camwheel relative to the support structure and the pivot arm causes thepivot arm to pivot about the axis and the forehead support to moveeither forward or backward along a path of movement.

In an alternative embodiment, a patient interface device is providedthat includes a cushion member having a main body portion having asurface structured to engage the face of a patient, a frame membercoupled to the cushion member, the frame member being structured to becoupled to a headgear, a fluid coupling conduit coupled to a first sideof the frame member, an engagement member coupled to the cushion member,and a rotatable cam wheel disposed between a second side of the framemember and the engagement member, wherein a first surface of the camwheel engages the engagement member such that rotation of the cam wheelrelative to the cushion member changes a position of the main bodyportion relative to the frame member.

In yet another embodiment, a patient interface device is provided thatincludes a cushion member having a main body portion having a surfacestructured to engage a face of a patient, a frame member coupled to thecushion member, the frame member being structured to be coupled to aheadgear, a fluid coupling conduit coupled to a first side of the framemember, one or more first magnets coupled to the cushion member, the oneor more first magnets having a first polarity, and a rotatable cam wheeldisposed between a second side of the frame member and the one or morefirst magnets. The cam wheel includes one or more second magnets facingtoward the one or more first magnets and having a second polarityopposite the first polarity, wherein rotation of the cam wheel relativeto the cushion member changes a position of the main body portionrelative to the frame member as a result of opposing forces between theone or more first magnets and one or more of the plurality of secondmagnets.

These and other objects, features, and characteristics of the presentinvention, as well as the methods of operation and functions of therelated elements of structure and the combination of parts and economiesof manufacture, will become more apparent upon consideration of thefollowing description and the appended claims with reference to theaccompanying drawings, all of which form a part of this specification,wherein like reference numerals designate corresponding parts in thevarious figures. It is to be expressly understood, however, that thedrawings are for the purpose of illustration and description only andare not intended as a definition of the limits of the invention. As usedin the specification and in the claims, the singular form of “a”, “an”,and “the” include plural referents unless the context clearly dictatesotherwise.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an isometric view of a patient interface device according toone exemplary embodiment of the present invention;

FIG. 2 is an exploded view of the patient interface device of FIG. 1;

FIGS. 3A-3E are top plan, bottom plan, right side elevational, top sideelevational, and isomeric views, respectively, of a cam wheel formingpart of the patient interface device of FIGS. 1 and 2;

FIG. 4 is an isometric view of a patient interface device according toan alternative exemplary embodiment of the present invention;

FIG. 5 is an isometric view of a patient interface device according to afurther alternative exemplary embodiment of the present invention; and

FIGS. 6A-6E are top plan, bottom plan, right side elevational, top sideelevational, and isomeric views, respectively, of a cam wheel formingpart of the patient interface device of FIGS. 4 and 5;

FIGS. 7 and 8 are schematic diagrams of a system adapted to provide aregimen of respiratory therapy to a patient according to anotherexemplary embodiment;

FIG. 9 is an isometric view of a cushion assembly forming a part of apatient interface device of the system of FIGS. 7 and 8 according to theexemplary embodiment;

FIG. 10 is a side elevational view of a cushion member forming a part ofthe cushion assembly of FIG. 9;

FIGS. 11A, 11B and 11C are an isometric view, a side elevational viewand a top plan view, respectively, of a ring member forming a part ofthe cushion assembly of FIG. 9;

FIG. 12 is an isometric view of a frame member forming a part of thecushion assembly of FIG. 9;

FIGS. 13A-13D show various views of a cam wheel forming a part of apatient interface device of the system of FIGS. 7 and 8 according to theexemplary embodiment;

FIG. 14 is an isometric view of a fluid coupling conduit forming a partof a patient interface device of the system of FIGS. 7 and 8 accordingto the exemplary embodiment;

FIGS. 15A and 15B are top and bottom plan views, respectively, of apatient interface device of the system of FIGS. 7 and 8 according to theexemplary embodiment; and

FIG. 16 is an isometric view of an alternative ring member, and FIGS.17A and 17B are side elevational and top plan views, respectively, of analternative cam wheel that may be employed to create a patient interfaceaccording to an alternative exemplary embodiment of the invention.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

As used herein, the singular form of “a”, “an”, and “the” include pluralreferences unless the context clearly dictates otherwise. As usedherein, the statement that two or more parts or components are “coupled”shall mean that the parts are joined or operate together either directlyor indirectly, i.e., through one or more intermediate parts orcomponents, so long as a link occurs. As used herein, “directly coupled”means that two elements are directly in contact with each other. As usedherein, “fixedly coupled” or “fixed” means that two components arecoupled so as to move as one while maintaining a constant orientationrelative to each other.

As used herein, the word “unitary” means a component is created as asingle piece or unit. That is, a component that includes pieces that arecreated separately and then coupled together as a unit is not a“unitary” component or body. As employed herein, the statement that twoor more parts or components “engage” one another shall mean that theparts exert a force against one another either directly or through oneor more intermediate parts or components. As employed herein, the term“number” shall mean one or an integer greater than one (i.e., aplurality).

FIG. 1 is an isometric view and FIG. 2 is an exploded view of a patientinterface device 2 according to one exemplary embodiment of the presentinvention. Patient interface device 2 includes a patient coupling member4, which in the illustrated embodiment is a nasal mask. However, anytype of patient sealing element or other mechanism for communicating aflow of gas with an airway of a user, such as a nasal/oral mask, a fullface mask, nasal cannula, that facilitates the delivery of a flow ofbreathing gas to the airway of a patient, may be used as patientcoupling member 4 while remaining within the scope of the presentinvention. Patient coupling member 4 is coupled to elbow conduit 6,which, in turn, is coupled to pivot arm conduit 8. Pivot arm conduit 8is structured to be coupled to a delivery conduit (not shown) which isin fluid communication with a pressure generating device (also notshown) that is structured to generate a flow of breathing gas which isdelivered to the patient through patient coupling member 4.

The pressure generating device may include, without limitation, aventilator, constant pressure support device (such as a continuouspositive airway pressure device, or CPAP device), a variable pressuresupport device (e.g., BIPAP®, Bi-Flex®, or C-Flex™ devices manufacturedand distributed by Philips Respironics of Murrysville, Pa.), or anauto-titration pressure support device. In one exemplary embodiment, thedelivery conduit that is coupled to pivot arm conduit 8 is adapted toextend over the patient's head when a headgear assembly 10 of patientinterface device 2, described below, is worn on the head of the patient.

As noted above, patient interface device 2 includes a headgear assembly10 adapted to fit over/around the patient's head to hold patientcoupling member 4 in place on the face of the patient. Headgear assembly10 includes a rigid support structure 12 adapted to fit over theforehead, top and rear portions of the patient's head. Support structure12 includes a base portion 14 having arms 16, 18 extending therefrom. Inaddition, base portion 14 has an extension member 20 extending from afirst side thereof and an extension member 24 extending from a secondside thereof. Each extension member 20, 24 includes a respective loop22, 26, which is structured to receive a respective headgear strap 28,30 of headgear assembly 10 for securing headgear assembly 10 and thuspatient interface device 2 to the head of the patient.

Base portion 14 of support structure 12 further includes a post portion32 extending from a front face thereof. Post portion 32 includes a postarm 34 having aperture 38 formed therein, and a post arm 36 having anaperture 40 formed therein. Patent interface device 2 also includes acam wheel 42 that is described in greater detail below in connectionwith FIGS. 3A-3E, which are top plan, bottom plan, right sideelevational, top side elevational, and isomeric views, respectively, ofthe cam wheel. Cam wheel 42 includes central bore 44.

As seen in FIG. 1, when patient interface device 2 is assembled, camwheel 42 is placed over post portion 32 in a manner in which post arms34, 36 of post portion 32 are received through central bore 44 of camwheel 42. Cam wheel 42 is free to rotate about post portion 32. Inaddition, as seen in FIG. 2, the top end 46 of pivot arm conduit 8includes posts 48, 50 on opposite sides thereof. As seen in FIG. 1, whenpatient interface device 2 is assembled, each post 48, 50 of pivot armconduit 8 is rotateably received and held within a respective aperture38, 40 of base portion 14. Pivot arm conduit 8, when so mounted to baseportion 32, secure and holds cam wheel 42 in place between pivot armconduit 8 and base portion 14. In addition, as seen in FIG. 1, pivot armconduit 8 will always contact cam wheel 42 in two places as cam wheel 42is rotated about post portion 32.

Referring to FIGS. 3A-3E, in an exemplary embodiment, cam wheel 42 is acylindrically shaped member having left and right outside walls 52, 54that vary in height from a maximum at top middle portion 56 of cam wheel42 to a minimum at bottom middle portion 58 of cam wheel 42. Moreparticularly, in the illustrated embodiment, the height of each of leftoutside wall 52 and right outside wall 54 tapers and decreases linearlyfrom top middle portion 56 to bottom middle portion 58. Left and rightoutside walls 52, 54 are provided with ridges 66 to facilitate grippingand turning of cam wheel 42 as described elsewhere herein. While angenerally linear change in height for the wall of the cam wheel isshown, it is to be understood that the present invention contemplatesthat the wall of the cam wheel can have other shapes or changes inheight.

As noted above, pivot arm conduit 8 will always contact cam wheel 42 intwo places as cam wheel 42 is rotated about post portion 32. Thus, inoperation, when a patient dons patient interface device 2, patientcoupling member 4 will engage the patient's face. As the patientselectively rotates cam wheel 42 about post portion 32, the varyingheight of the walls of cam wheel 42 as defined by left and right outsidewalls 52, 54 and the two points of contact between cam wheel 42 andpivot arm conduit 8 described above will cause pivot arm conduit 8 topivot about the axis through pivot arm conduit 8 that is defined byposts 48, 50. Such pivoting causes bottom end 68 of pivot arm conduit 8,and thus patient coupling member 4 attached thereto, to move inwardlyand outwardly along a defined path of movement in a correspondingfashion.

Stated another way, rotation of cam wheel 42 results in movement ofpatient coupling member 4 relative to support structure 12. In thisembodiment, support structure 12 is fixed on the user's head. As aresult, when the cam wheel is actuated the patient coupling member movestoward or away from the user's face, thus adjusting the force of theseal provided by the patient coupling member against the face of theuser.

Pivot arm conduit 8, post portion 32, and cam wheel 42, as justdescribed, thus provides an easy to use, reduced complexity adjustmentmechanism for patient interface device 2. Because cam wheel 42 is ableto be turned both clockwise and counter clockwise, the position ofpatient coupling member 4 can be readily and easily adjusted bothinwardly and outwardly relative to the patient's airway when the patientinterface device is worn by the user. Furthermore, as the outer diameterof cam wheel 42 is made larger, it becomes easier to use by people withless strength and/or dexterity in their hands, such as the elderly.

FIG. 4 is an isometric view of a patient interface device 70 accordingto an alternative exemplary embodiment of the present invention. Patientinterface device 70 includes patient coupling member 72 that, like inthe previous embodiment, is also a patient sealing element that seals anairway of the user. In this illustrated exemplary embodiment, thepatient sealing element is a nasal mask that includes a cushion thatcontacts the face of the user. However, any type of patient couplingmember, such as a nasal/oral mask, nasal cannula or a full face mask,which facilitates the delivery of a flow of breathing gas to the airwayof a patient, may be used as patient coupling member 72 while remainingwithin the scope of the present invention. Patient coupling member 72(i.e., the cushion) is fluidly coupled to a rigid support structure 74which in turn is coupled to elbow conduit 76. Elbow conduit 76 isstructured to be coupled to a delivery conduit (not shown) which is influid communication with a pressure generating device (also not shown)that is structured to generate a flow of breathing gas which isdelivered to the patient through patient coupling member 72.

Support structure 74 includes a base portion 78 having a post portion 80extending therefrom. In addition, post portion 80 has a pair of posts 82extending from opposites side thereof. Support structure 74 furtherincludes a pair of extension members 84 extending from opposites sidethereof, wherein each extension member 84 includes a loop 86 which isstructured to receive a respective lower headgear strap of a headgearassembly (not shown) for securing patient interface device 70 to thehead of the patient.

Patient interface device 70 further includes a forehead support 88 thatincludes forehead cushion 90 that is coupled to support frame 92.Forehead support 88 is structured to provide additional support forpatient interface device 70 by engaging the forehead of the patient.Support frame 92 includes loops 94 provided at opposite ends thereof.Each loop 94 is structured to receive a respective upper headgear strapof a headgear assembly (not shown) for securing patient interface device70 to the head of the patient. Support frame 92 is pivotably coupled toupper end 96 of a support arm 98. The present invention contemplatesthat the forehead support can have any configuration. For example, thelength of support arm 98 can be made adjustable. Also, the foreheadcushion can include one or more cushions having any suitableconfiguration. Also, headgear attaching elements in addition to or otherthan loops 94 can be provided on the forehead support.

A lower end 100 of support arm 98 includes a loop portion 102 that isstructured to receive therethrough post portion 80 of support structure74, as shown in FIG. 4. In addition, prior to loop portion 102 beinginserted over post portion 80 as just described, cam wheel 42′ accordingto an alternative embodiment shown in FIGS. 6A-6E, is inserted over postportion 80 such that post portion 80 is received through central bore 44of cam wheel 42′. Cam wheel 42′ is similar to cam wheel 42, and likeparts are labeled with like reference numerals. However, as seen inFIGS. 6A-6E, interior wall 60 of cam wheel 42′ includes notches 62, 64for providing clearance for post 82 as cam wheel 42′ is slid over postportion 80. The bottom edge of cam wheel 42 then rests against baseportion 78, and cam wheel is permitted to rotate about post portion 80.In addition, post portion 80 is received through loop portion 102, eachpost 82 is received and held within a respective aperture 104 providedon opposite sides of loop portion 102 such that loop portion 102 andsupport arm 98 are able to pivot about the axis defined by posts 82.Also, cam wheel is held in place between lower end 100 of support arm 98and base portion 78 as a result of the engagement between loop portion102 and post portion 80.

As shown in FIG. 4, lower end 100 of support arm 98 will always contactcam wheel 42′ in two places as cam wheel 42′ is rotated about postportion 80. Thus, in operation, when a patient dons patient interfacedevice 70, patient coupling member 72 will engage the patient's face andforehead support 88 will engage the patient's forehead. As the patientselectively rotates cam wheel 42 about post portion 80, the varyingheight of the walls of cam wheel 42′ as defined by left and rightoutside walls 52, 54 and the two points of contact between cam wheel 42and lower end 100 of support arm 98 described above will support arm 98to pivot about the axis through that is defined by posts 82. Suchpivoting causes forehead support 88 to move inwardly and outwardly alonga defined path of movement in a corresponding fashion so that it mayreadily and easily be adjusted by the patient relative to patientcoupling member 72. Thus, support arm 98 serves as a pivot arm that ispivotably coupled to support structure 74.

It can be appreciated that rotation of cam wheel 42′ results in movementof forehead support 88 relative to patient coupling member. In thisembodiment, support structure 12 is fixed on the user's head. As aresult, when the cam wheel is actuated the patient coupling member movestoward or away from the user's face, thus adjusting the force of theseal provided by the patient coupling member against the face of theuser

FIG. 5 is an isometric view of a patient interface device 106 accordingto an alternative exemplary embodiment of the present invention. Patientinterface device is similar to patient interface device 70, and likecomponents are labeled with like reference numerals. Patient interfacedevice 106, however, includes patient coupling member 108, which is anasal/oral mask that covers the nose and mouth, and alternative rigidsupport structure 110 to which patient coupling member 108 is fluidlycoupled.

A system 120 adapted to provide a regimen of respiratory therapy to apatient according to another exemplary embodiment is generally shown inFIGS. 7 (isometric view) and 8 (side view). System 120 includes apressure generating device 122, a delivery conduit 124, and a patientinterface device 126. Pressure generating device 122 is structured togenerate a flow of breathing gas and may include, without limitation,ventilators, constant pressure support devices (such as a continuouspositive airway pressure device, or CPAP device), variable pressuredevices (e.g., BiPAP®, Bi-Flex®, or C-Flex™ devices manufactured anddistributed by Philips Respironics of Murrysville, Pa.), andauto-titration pressure support devices. Delivery conduit 124 isstructured to communicate the flow of breathing gas from pressuregenerating device 122 to patient interface device 126. Delivery conduit124 and patient interface device 126 are often collectively referred toas a patient circuit.

As seen in FIGS. 7 and 8, in the exemplary embodiment, patient interface126 includes a cushion assembly 128, which in the illustrated embodimentis a nasal mask structured to fit over the nose and of the patient 1.However, other types of cushion assemblies, such as, without limitation,a nasal/oral mask or a nasal cushion, which facilitate the delivery ofthe flow of breathing gas to the airway of a patient, may be substitutedfor cushion assembly 128 while remaining within the scope of the presentinvention. Patient interface 126 further includes a cam wheel 130, afluid coupling conduit 132, and headgear clips 134A, 134B. Cushionassembly 128, cam wheel 130, fluid coupling conduit 132, and headgearclips 134A, 134B are each described in greater detail below. It can beappreciated that this embodiment differs from the previous embodiment inFIGS. 4 and 5, in that the forehead support has been omitted.

FIG. 9 is an isometric view of cushion assembly 128 according to theexemplary embodiment. Cushion assembly 128 includes a cushion member 136having a ring member 138 and a frame member 140 coupled thereto.

FIG. 10 is a side elevational view of cushion member 136. Cushion member136 is defined from a unitary piece of soft, flexible, cushiony,elastomeric material, such as, without limitation, silicone, anappropriately soft thermoplastic elastomer, closed cell foam, or anycombination of such materials. As seen in FIGS. 9 and 10, cushion member136 includes a main body portion 142 defining a chamber for receivingbreathing gasses and having a patient sealing surface 144 structured toengage the face of a patient. Cushion member 136 also includes a bellowsportion 146 adjacent to main body portion main body portion 142. Bellowsportion 146 includes pleats 148A and 148B and is structured to beextendible along the longitudinal axis 150 of cushion member 136 in themanner described elsewhere herein.

In the exemplary embodiment, cushion assembly 128 is formed byovermolding cushion member 136 onto ring member 138 and frame member140. In particular, as a result of such a process, ring member 138 ispositioned at a junction 152 of main body portion 142 and bellowsportion 148 of cushion member 136, and frame member 140 is positioned ata distal end 154 of bellows section 146 that is fluidly coupled to fluidcoupling conduit 132.

FIGS. 11A, 11B and 11C are an isometric view, a side elevational viewand a top plan view, respectively, of ring member 138 according to theexemplary embodiment. Ring member 138 generally has a saddle-like shapeand includes a first arcuate member 156A joined to a second arcuatemember 156B. As seen best in FIG. 11C, each arcuate member 156A, 156B isconfigured such that the rear side thereof forms an acute angle withrespect to the longitudinal axis 158 thereof. In other words, eacharcuate member 156A, 156B is angled/disposed rearwardly with respect toa front side of ring member 138 such that the angle between the rearsurfaces of arcuate members 156A and 156B is less than 180 degrees. Inaddition, frame member 138 includes top and bottom engagement surfaces160A and 160B, at the junction points of arcuate member 156A, 156B. Thefunction of engagement surfaces 160A and 160B is described elsewhereherein. In addition, ring member 138 has a plurality of orifices 162 forfacilitating the overmolding process described above.

FIG. 12 is an isometric view of frame member 140 according to theexemplary embodiment. Frame member 140 has a main body 164 having agenerally annular shape. Main body 164 includes a circumferential ridgemember 166 which is structured to enable a fluid tight connection to bemade to fluid coupling conduit 132. In addition, frame member 140includes arms 168A and 168B extending from opposite sides of main body164. Arms 168A and 168B are structured to receive and hold headgearclips member 134A, 134B, which in turn are structured to be coupled tothe straps of a headgear component (not shown) for securing patientinterface device 126 to the head of the patient. Finally, frame member140, like ring member 138, has a plurality of orifices 170 forfacilitating the overmolding process described above.

FIGS. 13A and 13B are isometric and side elevational views,respectively, of cam wheel 130 according to the exemplary embodiment.Cam wheel 130 is a cylindrically shaped member having first and secondoutside walls 172, 174 that define a top surface 173 and a bottomsurface 175 of cam wheel 130. As seen in FIGS. 13A and 13B, first andsecond outside walls 172, 174 vary in height from a maximum at topmiddle portion 176 of cam wheel 130 to a minimum at bottom middleportion 178 of cam wheel 130. More particularly, in the illustratedembodiment, the height of each of first outside wall 172 and secondoutside wall 174 tapers and decreases linearly from top middle portion176 to bottom middle portion 178. First and second outside walls 172,174 are provided with ridges 180 to facilitate gripping and turning ofcam wheel 130 as described elsewhere herein. While a generally linearchange in height for the wall of the cam wheel is shown, it is to beunderstood that the present invention contemplates that the wall of thecam wheel can have other shapes or changes in height. In addition, inthe exemplary embodiment, cam wheel 130 is formed in two pieces, shownin FIGS. 13D and 13E, that are then fit together by a suitablemechanism, such as a snap fit, a friction fit or an adhesive. In theexemplary embodiment, first outside wall 172 includes tabs 182 that arestructured to be received within slots 184 provided in second outsidewall 174.

FIG. 14 is an isometric view of fluid coupling conduit 132. As seen inFIG. 14, fluid coupling conduit 132 includes a cylindrical firstconnector portion structured to be attached to delivery conduit 124, anda hemispherical second connector portion 188 structured to be attachedto cushion assembly 128. Second connector portion 188 defines a chamberhaving an exhaust port 190 comprising a plurality of orifices forexhausting exhaled gasses to atmosphere.

In the exemplary embodiment, patient interface device 126 is thusassembled by snapping cam wheel 130 together as just described overbellows portion 146 of cushion member 136 of cushion assembly 128. Fluidcoupling conduit 132 is then attached to circumferential ridge member166 of frame member 140 as seen in FIGS. 7 and 8 When this is done, camwheel 130 is able to freely rotate about bellows portion 146. Inaddition, as shown in FIGS. 15A and 15B, bottom surface 175 of cam wheel130 will engage the rear of main body 164 of frame member 140, andcorresponding, opposite points of top surface 173 will engage top andbottom engagement surfaces 160A and 160B of frame member 138.

In operation, the patient is able to adjust the position of main bodyportion 142 of cushion assembly 128 (see arrows in FIGS. 8, 15A and 15B)to increase comfort and seal by rotating cam wheel 130. In particular,as cam wheel 130 is rotated relative to bellows portion 146, differentpoints of top surface 173 will engage top and bottom engagement surfaces160A and 160B of frame member 138, causing pleats 148A and 148B ofbellows portion 146 to expand or contract relative to longitudinal axis150 of cushion member 136 depending on the particular height of firstand second outside walls 172, 174 at the then engaging points of topsurface 173. As a result, main body portion 142 will move relative tothe longitudinal axis 150 of cushion member 136.

FIG. 16 is an isometric view of an alternative ring member 138′, andFIGS. 17A and 17B are side elevational and top plan views, respectively,of an alternative cam wheel 130′ that may be employed in place of ringmember 138 and cam wheel 130 to create a patient interface according toan alternative exemplary embodiment of the invention. Ring member 138′is similar to ring member 138, and like portions are labeled with likereference numerals. However, as seen in FIG. 16, ring member 138′differs in that it includes first permanent magnet members 192A, 192Bhaving a first polarity at the junction points of arcuate member 156A,156B (i.e., the locations of top and bottom engagement surfaces 160A and160B in ring member 138). In addition, cam wheel 130′ is a cylindricallyshaped member having outside walls that define a top surface 173′ and abottom surface 175′ of cam wheel 130′. As seen in FIG. 17A, the outsidewalls of cam wheel 130′ do not vary in height. In addition, a pluralityof permanent magnet members are provided on top surface 173′. Inparticular, those magnet members all have a second polarity that isopposite the first polarity of magnet members 192A, 192B, and includefirst magnet members 194A, 194B located opposite one another and havinga first strength, second magnet members 196A, 196B located opposite oneanother and having a second strength greater than the first strength,and third magnet members 198A, 198B located opposite one another andhaving a third strength greater than the second strength. Alternatively,the permanent magnet members provided on top surface 173′ may havedifferent sizes to yield different magnetic opposing forces.

In operation, when ring member 138′ and cam wheel 130′ are employed inplace of ring member 138 and cam wheel 130 to create a patient interfacesimilar to patient interface 126, the patient is able to adjust theposition of main body portion 142 of cushion assembly 128 to increasecomfort and seal by rotating cam wheel 130′. In particular, as cam wheel130′ is rotated relative to bellows portion 146, different pairs ofmagnet members 194A, 194B, 196A, 196B, and 198A, 198B will be positionedadjacent magnet members 192A, 192B of ring member 138′ to provide anopposing force with respect thereto (based on the opposite polarity ofthe magnet members). The opposing magnetic forces will cause pleats 148Aand 148B of bellows portion 146 to expand or contract relative tolongitudinal axis 150 of cushion member 136 to a certain degree (i.e., acertain amount) depending on the strength (or size) of the pairs ofmagnet members 194A, 194B, 196A, 196B, and 198A, 198B that are thenadjacent to and therefore opposing magnet members 192A, 192B of ringmember 138′. As a result, main body portion 142 will move relative tothe longitudinal axis 150 of cushion member 136 (by an amount determinedby the particular opposing magnets).

In the embodiments described above, rotating the cam wheel causes thepatient coupling member to move or flex in a direction that causes thecushion to move in a longitudinal direction, i.e., to move generallyin-line with a center-line of the user. This allows the user, forexample, to adjust the pressure applied by cushion at the bridge of thenose. The present invention also contemplate moving the patient couplingmember in other directions, such as laterally, using the cam wheel orusing multiple cam wheels. In addition, other adjustment mechanisms canbe provided with the patient interface device.

Although the invention has been described in detail for the purpose ofillustration based on what is currently considered to be the mostpractical and preferred embodiments, it is to be understood that suchdetail is solely for that purpose and that the invention is not limitedto the disclosed embodiments, but, on the contrary, is intended to covermodifications and equivalent arrangements that are within the spirit andscope of the appended claims. For example, it is to be understood thatthe present invention contemplates that, to the extent possible, one ormore features of any embodiment can be combined with one or morefeatures of any other embodiment.

What is claimed is:
 1. A patient interface device, comprising: a cushionmember having a main body portion having a surface structured to engagea face of a patient; a frame member coupled to the cushion member, theframe member being structured to be coupled to a headgear; a fluidcoupling conduit coupled to a first side of the frame member; anengagement member coupled to the cushion member; and a rotatable camwheel disposed between a second side of the frame member and theengagement member, wherein a first surface of the cam wheel engages theengagement member such that rotation of the cam wheel relative to thecushion member changes a position of the main body portion relative tothe frame member, wherein rotation of the cam wheel relative to thecushion member moves the main body portion relative to the frame memberalong a longitudinal axis of the cushion member, wherein the cushionmember includes a flexible portion adjacent the main body portion,wherein the cam wheel is rotatable about the flexible portion, andwherein rotation of the cam wheel about the flexible portion causes theflexible portion to deflect thereby moving the cushion member relativeto the frame member.
 2. The patient interface device according to claim1, wherein the flexible portion includes a pleat that is expandablealong the longitudinal axis of the cushion member.
 3. The patientinterface device according to claim 1, wherein the engagement membercomprises a ring member surrounding the cushion member at an end of theman body portion opposite the surface structured to engage the face ofthe patient, and wherein the engagement member continuously engages thecam wheel at only two locations on the first surface of the cam wheel asthe cam wheel is rotated.
 4. The patient interface device according toclaim 3, wherein the engagement member includes a first engagementsurface location and a second engagement surface location that engagethe cam wheel at the two locations.
 5. The patient interface deviceaccording to claim 4, wherein the first engagement surface location andthe second engagement surface location are located directly opposite oneanother about a perimeter of the engagement member.
 6. The patientinterface device according to claim 4, wherein the ring member generallyhas a saddle-like shape and includes a first arcuate member and a secondarcuate member joined to one another at the first and second engagementsurface locations.
 7. The patient interface device according to claim 6,wherein the first arcuate member and the second arcuate member are eachdisposed rearwardly with respect to a front side of the ring member suchthat an angle between respective rear surfaces of the first arcuatemember and the second arcuate member is less than 180 degrees.
 8. Thepatient interface device according to claim 3, wherein the cam wheelwraps around the flexible portion, wherein the cam wheel has first andsecond outside walls, wherein both the first outside wall and the secondoutside wall vary in height from a maximum at a top middle portion ofthe cam wheel to a minimum at a bottom middle portion of the cam wheel.9. The patient interface device according to claim 8, wherein the heightof each of the first outside wall and the second outside wall tapers anddecreases linearly from the top middle portion to the bottom middleportion.
 10. The patient interface device according to claim 1, whereinthe frame member has a first arm having a first headgear clip attachedthereto and a second arm having a second headgear clip attached thereto.11. A patient interface device, comprising: a cushion member having amain body portion having a surface structured to engage a face of apatient; a frame member coupled to the cushion member, the frame memberbeing structured to be coupled to a headgear; a fluid coupling conduitcoupled to a first side of the frame member; one or more first magnetscoupled to the cushion member, the one or more first magnets having afirst polarity; and a rotatable cam wheel disposed between a second sideof the frame member and the one or more first magnets, the cam wheelincluding one or more second magnets facing toward the one or more firstmagnets and having a second polarity opposite the first polarity,wherein rotation of the cam wheel relative to the cushion member changesa position of the main body portion relative to the frame member as aresult of opposing forces between the one or more first magnets and oneor more of the plurality of second magnets.
 12. The patient interfacedevice according to claim 11, wherein the one or more second magnetscomprise a plurality of second magnets having different strengths orsizes.
 13. The patient interface device according to claim 11, whereinthe one or more first magnets are provided on a ring member coupled tothe cushion member.
 14. The patient interface device according to claim11, wherein rotation of the cam wheel relative to the cushion membermoves the main body portion relative to the frame member along alongitudinal axis of the cushion member.